[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581421":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":57,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAS-102 group","EXPERIMENTAL","Neoadjuvant long-course radiotherapy combined with TAS-102",[13],"Combination Product: TAS-102",{"label":15,"type":16,"description":17,"interventionNames":18},"Capecitabine group","ACTIVE_COMPARATOR","Neoadjuvant long-course radiotherapy combined with capecitabine",[19],"Combination Product: Capecitabine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","TAS-102","Radiotherapy:\n\n1. Radiotherapy Technique: Three-dimensional conformal radiotherapy (3D-CRT), intensity-modulated radiotherapy (IMRT), or volume modulated arc therapy (VMAT);\n2. Radiotherapy Dose and Fractionation Schedule: Conventional fractionation with external beam irradiation at a dose of 50 Gy delivered in 25 fractions over 5 weeks.\n\nSynchronous Chemotherapy:\n\nConcurrent administration of TAS-102 at a dose of 35 mg\u002Fm² twice daily at the 1st, 3rd and 5th week of radiotherapy.\n\nIntermittent Consolidation Chemotherapy:\n\nOxaliplatin at 85 mg\u002Fm² on day 1 combined with TAS-102 at 35 mg\u002Fm² twice daily from day 1 to day 5, repeated every 14 days for a total of 6 cycles.\n\nSurgery:\n\nThe operation follows the principle of TME. The type of surgery depends on the location and extent of the primary tumor.\n\nPostoperative adjuvant therapy:\n\nTwo cycles of CapeOX (Oxaliplatin 130 mg\u002Fm2 on day 1+ capecitabine 1000 mg\u002Fm2 twice a day on days 1-14, q3w).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Capecitabine","Radiotherapy:\n\n1. Radiotherapy Technique: Three-dimensional conformal radiotherapy (3D-CRT), intensity-modulated radiotherapy (IMRT), or volume modulated arc therapy (VMAT);\n2. Radiotherapy Dose and Fractionation Schedule: Conventional fractionation with external beam irradiation at a dose of 50 Gy delivered in 25 fractions over 5 weeks.\n\nSynchronous Chemotherapy:\n\nCapecitabine administered orally at a dose of 825 mg\u002Fm² twice daily on days of radiotherapy.\n\nIntermittent Consolidation Chemotherapy:\n\nOxaliplatin at 130 mg\u002Fm² on day 1 combined with capecitabine at 1000 mg\u002Fm² twice daily from day 1 to day 14, repeated every 21 days for a total of 4 cycles.\n\nSurgery:\n\nThe operation follows the principle of TME. The type of surgery depends on the location and extent of the primary tumor.\n\nPostoperative adjuvant therapy: Two cycles of CapeOX (Oxaliplatin 130 mg\u002Fm2 on day 1+ capecitabine 1000 mg\u002Fm2 twice a day on days 1-14, q3w)",[15],[32],{"name":33,"affiliation":5,"role":34},"Jinbo Yue, Docter","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","0531-67626442","jbyue@sdfmu.edu.cn",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Jinan","Shandong","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.99722,36.66833,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":38,"phoneExt":26,"email":56},"Jinbo Yue, Doctor","jbyue@sdfmu.ed",{"type":34,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jinbo Yue","Director of Radiation Oncology Department","100581421","phase-3-neoadjuvant-radiotherapy-for-rectal-adenocarcinoma-with-capecitabine-versus-tas-102-neo-react-a-multi-center-randomized-phase-iii-trial-100581421",false,"NCT06850090","Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial","Inclusion Criteria:\n\n1. Patients aged between 18 and 75 years of either sex.\n2. Histologically confirmed rectal adenocarcinoma with the following conditions:\n\n   1. Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.\n   2. The tumor is located within 12 cm from the anal margin, with at least one high-risk factors (ie, extramural vascular invasion \\[EMVI+\\], mesorectal fascia involved \\[MRF+\\], cT4, cN2, lateral lymph nodes, tumor deposit, or tumor located in the lower rectum \\[≤5 cm from the anal verge\\]).\n3. No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer.\n4. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Estimated life expectancy \\> 6 months.\n\nExclusion Criteria:\n\n1. Patients of dMMR or MSI-H status.\n2. Unexplained myelosuppression.\n3. Evidence of distant metastasis and inguinal lymph node metastasis based on comprehensive chest and abdominal CT or whole-body PET-CT scans. Retroperitoneal lymph nodes above the iliac vessel bifurcation are considered distant metastasis.\n4. Active autoimmune disease or history of autoimmune disease.\n5. Uncontrolled cardiac symptoms or diseases.\n6. History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.","ALL","18 Years","75 Years",{"count":70,"type":71},210,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","Neoadjuvant fluoropyrimidine-based chemoradiotherapy followed by total mesorectal excision (TME) is the standard of care for locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates are low. Trifluridine\u002Ftipiracil (TAS-102) is a new oral anti-tumor oral formulation of nucleoside analogue, trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI). Previous studies have shown that TAS-102 has shown clinically relevant activity after fluoropyrimidine failure in colorectal cancer and may thus be of increased efficacy compared with current standard capecitabine chemoradiation. Also, a phase 2 trials conducted by our team have demonstrated that neoaduvant TAS-102 concurrent with long-course radiotherapy could lead to a high pCR rate of 32% with acceptable toxicity for LARC patients. Herein, we will conduct this multicenter, randomized controlled, phase III trial to explore the safety and efficacy benefit of TAS-102 concurrent with long-course radiotherapy for LARC.",[77,78],"Rectal Cancer","Rectal Cancer Patients","2026-04-27",{"date":81,"type":82},"2026-04-28","ACTUAL",{"date":84,"type":82},"2025-07-30",{"date":86,"type":71},"2028-06",{"name":5,"class":6},1]